[Corporate and Clinical Program Highlights](index=1&type=section&id=Corporate%20and%20Clinical%20Program%20Highlights) Sensei Biotherapeutics updated on solnerstotug's Phase 1/2 data expected by year-end 2025 and corporate events [CEO Commentary and Strategy](index=1&type=section&id=CEO%20Commentary%20and%20Strategy) The CEO outlined solnerstotug's strategic shift, emphasizing its safety profile and potential in the PD-(L)1 resistant market - Solnerstotug, in combination with cemiplimab, has demonstrated a favorable safety profile with no significant additional toxicity compared to PD-(L)1 monotherapy[3](index=3&type=chunk) - The company envisions multiple Phase 2 studies for solnerstotug in PD-(L)1 resistant tumor types to target high-value segments of the **~$50 billion** PD-(L)1 market[3](index=3&type=chunk) - The final Phase 2 strategy will be strongly influenced by the full dose expansion dataset planned for presentation later in 2025[3](index=3&type=chunk) [Solnerstotug Clinical Program Update](index=1&type=section&id=Solnerstotug%20Clinical%20Program%20Update) The Phase 1/2 solnerstotug trial completed enrollment with 64 patients; full data expected by year-end 2025 - Full dose expansion data, including 6-month progression-free survival (PFS), from the Phase 1/2 study is expected by year-end 2025[5](index=5&type=chunk) Phase 1/2 Dose Expansion Cohort Enrollment | Arm | Patient Group | Number of Patients | | :--- | :--- | :--- | | Monotherapy | "Cold" MSS CRC | 10 | | Combination (with cemiplimab) | "Cold" MSS CRC | 10 | | Combination (with cemiplimab) | "Hot" Tumors (41/44 PD-(L)1 resistant) | 44 | | **Total** | | **64** | [Other Corporate Updates](index=2&type=section&id=Other%20Corporate%20Updates) Sensei announced favorable clinical data, an ESMO presentation, and regained Nasdaq compliance post-split - Clinical data from the dose expansion cohort will be presented at the European Society for Medical Oncology (ESMO) Congress in October 2025[11](index=11&type=chunk) - The company regained Nasdaq compliance after executing a 1-for-20 reverse stock split of its common stock, effective June 16th[11](index=11&type=chunk) - On March 27th, Sensei announced favorable preliminary clinical data from the dose expansion stage, demonstrating positive activity in patients with PD-(L)1 resistant "hot" tumors[11](index=11&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Sensei Biotherapeutics reported **$28.6 million** cash for Q2 2025, with reduced expenses and a **$4.9 million** net loss [Financial Performance Summary](index=2&type=section&id=Financial%20Performance%20Summary) Cash position was **$28.6 million** as of June 30, 2025, with reduced expenses and a **$4.9 million** net loss - Cash, cash equivalents, and marketable securities totaled **$28.6 million** as of June 30, 2025, which is expected to fund operations into the second quarter of 2026[7](index=7&type=chunk) Q2 2025 vs. Q2 2024 Operating Results (in millions) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | R&D Expenses | $2.5 million | $4.6 million | | G&A Expenses | $2.7 million | $3.2 million | | Net Loss | $4.9 million | $7.1 million | [Condensed Financial Statements](index=3&type=section&id=Condensed%20Financial%20Statements) Unaudited Q2 2025 statements show **$5.2 million** operating expenses, **$4.9 million** net loss, and **$31.8 million** total assets Condensed Statements of Operations (Unaudited, in thousands) | | Three Months Ended June 30, | | | :--- | :--- | :--- | | | **2025** | **2024** | | Research and development | $2,533 | $4,584 | | General and administrative | $2,673 | $3,203 | | **Total operating expenses** | **$5,206** | **$7,787** | | **Net loss** | **$(4,936)** | **$(7,142)** | | Net loss per share, basic and diluted | $(3.91) | $(5.69) | Selected Condensed Balance Sheet Data (Unaudited, in thousands) | | **June 30, 2025** | **December 31, 2024** | | :--- | :--- | :--- | | Cash and cash equivalents | $12,557 | $9,994 | | Marketable securities | $16,071 | $31,341 | | **Total assets** | **$31,783** | **$45,361** | | Total stockholders' equity | $27,314 | $38,386 | [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section outlines forward-looking statements on product development, clinical trials, and financial runway, subject to risks - Statements regarding product development, clinical trial timing for solnerstotug, and the company's cash runway are forward-looking and based on current expectations[15](index=15&type=chunk) - Key risks include the potential for product candidates not to be successfully developed or commercialized, delays in clinical trials, and prior results not being replicated in future studies[16](index=16&type=chunk) - The company refers to its Quarterly Report on Form 10-Q and other SEC filings for a more detailed description of risks and uncertainties[16](index=16&type=chunk)

Core Viewpoint - Sensei Biotherapeutics is transitioning from early response-focused readouts to longer-term efficacy signals in its Phase 1/2 study of solnerstotug, which shows a favorable safety profile and potential for better patient adherence and outcomes [2][3] Clinical Program Highlights - Full data for the Phase 1/2 dose expansion cohort is expected by year-end 2025, with enrollment complete at 64 patients [6] - The ongoing trial evaluates solnerstotug as a monotherapy and in combination with cemiplimab in patients with advanced solid tumors [3] - Preliminary clinical data indicates favorable activity in PD-(L)1 resistant "hot" tumors, with solnerstotug well tolerated and no dose-limiting toxicities reported [6] Corporate Updates - Sensei's cash position was $28.6 million as of June 30, 2025, down from $41.3 million at the end of 2024, with expectations to fund operations into Q2 2026 [8] - Research and Development expenses decreased to $2.5 million in Q2 2025 from $4.6 million in Q2 2024, attributed to lower personnel and facility costs [9] - General and Administrative expenses also decreased to $2.7 million in Q2 2025 from $3.2 million in Q2 2024, primarily due to lower personnel costs [10] Financial Results - The net loss for Q2 2025 was $4.9 million, an improvement from a net loss of $7.1 million in Q2 2024 [10] - Total operating expenses for Q2 2025 were $5.2 million, down from $7.8 million in Q2 2024 [13]

Core Insights - The broader stock market experienced significant losses due to trade policy changes and negative economic data, while select health technology stocks, including 4D Molecular Therapeutics, Sensei Biotherapeutics, and Alphatec Holdings, saw substantial gains averaging around 37% [1] Group 1: 4D Molecular Therapeutics - Shares of 4D Molecular Therapeutics surged over 42% to close at $6.42 following the release of promising clinical data for its gene therapy candidate, 4D-150, targeting diabetic macular edema and wet age-related macular degeneration [2] - The therapy showed strong, dose-dependent results, with a reported 78% reduction in treatment burden at the Phase 3 dose compared to standard aflibercept dosing, along with sustained visual improvements and no reported inflammation [4] - The European Medicines Agency endorsed the company's plan to seek approval based on a single Phase 3 trial, aligning with earlier FDA guidance [5] Group 2: Sensei Biotherapeutics - Sensei Biotherapeutics emerged as a top gainer despite no major company-specific news, likely due to increased speculative interest in its immuno-oncology pipeline and anticipation of upcoming trial data [6] - The stock rose 38% to close at $10.32, following the announcement that Sensei will present clinical data from its Phase 1/2 trial of its lead candidate at the European Society for Medical Oncology Congress on October 17 [7] Group 3: Alphatec Holdings - Alphatec Holdings' stock jumped 30% to close at $13.77 after the company raised its full-year 2025 revenue outlook to $742 million, driven by strong demand for its surgical platforms and EOS imaging technologies [9] - The company reported second-quarter 2025 revenue of $185.5 million, reflecting a 28% year-over-year increase, although it also reported a widened net loss of $41.1 million, or $0.27 per share [11] - Despite remaining unprofitable, investor confidence appears to be increasing in Alphatec's commercial execution and long-term growth prospects [12]

Core Insights - Sensei Biotherapeutics, Inc. announced the presentation of clinical data from the Phase 1/2 trial of solnerstotug, both alone and in combination with Libtayo, at the ESMO Congress 2025 in Berlin [1] Company Overview - Sensei Biotherapeutics is a clinical stage biotechnology company focused on developing next-generation therapeutics for cancer patients [2] - The company utilizes its TMAb™ platform to create conditionally active therapeutics that target immunosuppressive signals in the tumor microenvironment [2] - Solnerstotug is the lead product candidate, designed to block the VISTA checkpoint selectively in low pH tumor environments, enhancing T cell activation [2]

Core Viewpoint - Sensei Biotherapeutics, Inc. is implementing a 1-for-20 reverse stock split to comply with Nasdaq Capital Market's minimum bid price requirement, effective June 16, 2025 [1][3]. Group 1: Reverse Stock Split Details - The reverse stock split will reduce the number of issued and outstanding shares from approximately 25.2 million to about 1.3 million [3]. - The authorized shares will decrease from 250 million to 12.5 million [3]. - Fractional shares will not be issued; instead, stockholders entitled to fractional shares will receive a cash payment [4]. Group 2: Trading Information - The common stock will begin trading on a split-adjusted basis on June 17, 2025, under the existing trading symbol "SNSE" [2]. - Equiniti Trust Company, LLC will act as the exchange agent and transfer agent for the reverse stock split [5]. Group 3: Company Overview - Sensei Biotherapeutics focuses on developing next-generation therapeutics for cancer patients through its TMAb™ platform [6]. - The lead product candidate, solnerstotug, is designed to block the VISTA checkpoint selectively within the tumor microenvironment [6].

PART I FINANCIAL INFORMATION Presents the company's unaudited financial statements, management's analysis, and disclosures on market risk and internal controls [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) The unaudited financial statements for Q1 2025 show a net loss of **$6.9 million**, a decrease in total assets to **$38.3 million**, and an accumulated deficit of **$268.9 million**, raising substantial doubt about going concern [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $9,877 | $9,994 | | Marketable securities | $24,454 | $31,341 | | Total current assets | $35,682 | $41,929 | | **Total assets** | **$38,273** | **$45,361** | | **Liabilities & Equity** | | | | Total current liabilities | $5,229 | $5,448 | | **Total liabilities** | **$6,286** | **$6,975** | | **Total stockholders' equity** | **$31,987** | **$38,386** | | Accumulated deficit | $(268,916) | $(262,052) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Highlights (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | $3,725 | $4,917 | | General and administrative | $3,549 | $3,813 | | **Total operating expenses** | **$7,274** | **$8,730** | | Loss from operations | $(7,274) | $(8,730) | | **Net loss** | **$(6,864)** | **$(7,992)** | | Net loss per common share | $(0.27) | $(0.32) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(7,094) | $(7,616) | | Net cash provided by investing activities | $7,191 | $5,770 | | Net cash used in financing activities | $(214) | $(209) | | **Net decrease in cash and cash equivalents** | **$(117)** | **$(2,055)** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The company is a clinical-stage biotechnology firm focused on cancer therapeutics, but has incurred substantial losses, with an accumulated deficit of **$268.9 million** as of March 31, 2025[21](index=21&type=chunk)[22](index=22&type=chunk) - Management has concluded there is substantial doubt about the company's ability to continue as a going concern, as available cash is not sufficient to fund operations for more than **one year** without additional financing[23](index=23&type=chunk)[24](index=24&type=chunk) - In November 2024, the company initiated a restructuring to focus resources on the clinical development of its lead candidate, solnerstotug. This involved closing its Rockville, MD research site and reducing its workforce by approximately **46%**[71](index=71&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | $126 | $339 | | General and administrative | $335 | $877 | | **Total** | **$461** | **$1,216** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's strategic shift to focus on solnerstotug, resulting in reduced operating expenses and a cash runway into Q2 2026, while reiterating substantial doubt about its going concern ability [Overview](index=24&type=section&id=MD%26A%20-%20Overview) - The company is a clinical-stage biotechnology company focused on its TMAb™ (Tumor Microenvironment Activated Biologics) platform to develop therapeutics for cancer patients[75](index=75&type=chunk) - The lead product candidate, solnerstotug, is in a Phase 1/2 clinical trial for advanced solid tumors. Enrollment in the Phase 1 portion is complete, with updated data expected by the end of 2025[76](index=76&type=chunk) - A November 2024 restructuring paused development of preclinical candidates (SNS-102, SNS-103, SNS-201) and reduced the workforce by **46%** to focus resources on solnerstotug[77](index=77&type=chunk) [Results of Operations](index=28&type=section&id=MD%26A%20-%20Results%20of%20Operations) Comparison of Operations (in thousands) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $3,725 | $4,917 | $(1,192) | | General and administrative | $3,549 | $3,813 | $(264) | | **Total operating expenses** | **$7,274** | **$8,730** | **$(1,456)** | | **Net loss** | **$(6,864)** | **$(7,992)** | **$1,128** | - The **$1.2 million** decrease in R&D expenses was primarily due to lower personnel costs (**$0.8M**), facilities/equipment costs (**$0.4M**), and lab supply purchases (**$0.3M**), partially offset by a **$0.7M** increase in clinical trial expenses[95](index=95&type=chunk) - The **$0.3 million** decrease in G&A expenses was mainly attributable to lower personnel costs (**$0.6M**), partially offset by higher consulting and administrative fees[96](index=96&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=MD%26A%20-%20Liquidity%20and%20Capital%20Resources) - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities of **$34.3 million** and an accumulated deficit of **$268.9 million**[99](index=99&type=chunk) - The company expects its current cash to fund operating expenses and capital requirements into the second quarter of 2026[112](index=112&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern beyond **one year** from the financial statement issuance date, and additional financing is required to support operations[112](index=112&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is exempt from providing quantitative and qualitative disclosures about market risk - Sensei Biotherapeutics is a smaller reporting company as defined by Item 10 of Regulation S-K and is not required to provide quantitative and qualitative disclosures about market risk[127](index=127&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2025[130](index=130&type=chunk) - There were no material changes in internal control over financial reporting during the three months ended March 31, 2025[131](index=131&type=chunk) PART II OTHER INFORMATION Presents other required information including legal proceedings, risk factors, equity sales, and exhibits [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[134](index=134&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks including financial viability, dependence on solnerstotug, reliance on third parties, regulatory hurdles, commercialization challenges, intellectual property, and operational risks [Risks Related to our Financial Position](index=40&type=section&id=Risks%20Related%20to%20our%20Financial%20Position) - The company will need substantial additional funding to complete the development of its product candidates and a failure to obtain this capital could force it to delay, limit, or terminate its efforts[141](index=141&type=chunk) - The company has a history of significant losses, an accumulated deficit of **$268.9 million** as of March 31, 2025, and may never achieve profitability[153](index=153&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern, as current cash is only expected to fund operations into the second quarter of 2026[161](index=161&type=chunk) [Risks Related to the Development of our Product Candidates](index=46&type=section&id=Risks%20Related%20to%20the%20Development%20of%20our%20Product%20Candidates) - The company's development efforts are in early stages, and its business is highly dependent on the success of its one clinical candidate, solnerstotug[167](index=167&type=chunk)[181](index=181&type=chunk) - The therapeutic efficacy of solnerstotug is unproven in humans, and there are no currently approved therapies targeting its VISTA checkpoint, making development inherently risky[170](index=170&type=chunk) - Clinical trials are difficult, expensive, and have uncertain outcomes. Interim data may change, and failure to demonstrate safety and efficacy could halt development[187](index=187&type=chunk)[190](index=190&type=chunk)[193](index=193&type=chunk) [Risks Related to Manufacturing and our Dependence on Third Parties](index=61&type=section&id=Risks%20Related%20to%20Manufacturing%20and%20our%20Dependence%20on%20Third%20Parties) - The company relies on third-party CROs to conduct clinical trials and on CMOs for the production of solnerstotug, which increases risks related to performance, quality, cost, and supply[213](index=213&type=chunk)[227](index=227&type=chunk) - The clinical trial for solnerstotug is being evaluated in combination with cemiplimab, and the company depends on a supply agreement with Regeneron for this third-party drug[223](index=223&type=chunk) [Risks Related to Regulatory Approval and Legal Compliance](index=71&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20and%20Legal%20Compliance) - The company must obtain regulatory approval from the FDA and other authorities, a lengthy and uncertain process, before commercializing any product candidates[245](index=245&type=chunk) - Even if approved, the company will be subject to ongoing regulatory obligations, and any approved products could be subject to marketing restrictions, recalls, or withdrawal if safety issues arise[252](index=252&type=chunk) - Healthcare legislative reform, such as the Inflation Reduction Act (IRA), could adversely affect the business by impacting drug pricing, reimbursement, and profitability[263](index=263&type=chunk)[264](index=264&type=chunk)[266](index=266&type=chunk) [Risks Related to the Commercialization of our Product Candidates](index=83&type=section&id=Risks%20Related%20to%20the%20Commercialization%20of%20our%20Product%20Candidates) - The company currently has no sales, marketing, or distribution capabilities and will need to build them or partner with third parties to commercialize any approved products[279](index=279&type=chunk) - The biopharmaceutical industry is highly competitive, and the company faces competition from major pharmaceutical companies with greater resources[282](index=282&type=chunk)[285](index=285&type=chunk) - Commercial success depends on market acceptance by physicians and patients, as well as securing adequate coverage and reimbursement from government and private payors[289](index=289&type=chunk)[293](index=293&type=chunk) [Risks Related to Our Intellectual Property](index=89&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - The company's success depends on its ability to obtain and maintain patent protection for its technology and product candidates, which is an uncertain and expensive process[306](index=306&type=chunk) - The company may face lawsuits from third parties alleging infringement of their intellectual property rights, which could be costly and force a halt to commercialization[315](index=315&type=chunk) - The company relies on trade secrets and confidentiality agreements, which may be breached or may not provide adequate protection against competitors[330](index=330&type=chunk) [Risks Related to our Business Operations](index=99&type=section&id=Risks%20Related%20to%20our%20Business%20Operations) - The company's success depends on its ability to attract and retain key management and qualified scientific personnel in a highly competitive industry[339](index=339&type=chunk) - The November 2024 workforce reduction may have unintended consequences, including loss of institutional knowledge, decreased morale, and failure to achieve anticipated benefits[342](index=342&type=chunk) [Risks Related to our Securities and our Status as a Public Company](index=101&type=section&id=Risks%20Related%20to%20our%20Securities%20and%20our%20Status%20as%20a%20Public%20Company) - The company's stock price is likely to be highly volatile, and it has received a notice from Nasdaq for failing to meet the minimum **$1.00** bid price requirement[348](index=348&type=chunk)[354](index=354&type=chunk) - The company is an "emerging growth company" and a "smaller reporting company," which allows for reduced disclosure requirements that may make its stock less attractive to some investors[365](index=365&type=chunk) - Insiders own over **30%** of the company's common stock, giving them substantial influence over stockholder matters[379](index=379&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=116&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the quarter, and the use of IPO proceeds section is not applicable - There were no recent sales of unregistered equity securities during the reported period[404](index=404&type=chunk) [Item 3. Defaults Upon Senior Securities](index=118&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[407](index=407&type=chunk) [Item 4. Mine Safety Disclosures](index=118&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[408](index=408&type=chunk) [Item 5. Other Information](index=118&type=section&id=Item%205.%20Other%20Information) No officers or directors adopted, modified, or terminated Rule 10b5-1 trading arrangements during the quarter - During the quarter ended March 31, 2025, no officers or directors adopted, modified, or terminated a Rule 10b5-1 trading plan[409](index=409&type=chunk) [Item 6. Exhibits](index=118&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the report, including corporate documents and required Sarbanes-Oxley certifications - The exhibits filed with this report include certifications from the Principal Executive Officer and Principal Financial Officer as required by Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[410](index=410&type=chunk)

[Report Highlights and Corporate Updates](index=1&type=section&id=Report%20Highlights%20and%20Corporate%20Updates) Sensei Biotherapeutics announced a successful first quarter of 2025, highlighted by favorable clinical data for its lead candidate, solnerstotug, in difficult-to-treat PD-(L)1 resistant cancer patients. The company completed enrollment for its dose expansion study and confirmed a cash runway sufficient to fund operations into the second quarter of 2026 - Observed favorable signs of clinical activity in patients with PD-(L)1-resistant cancers, with response rates nearly **three times higher** than typically expected[1](index=1&type=chunk)[3](index=3&type=chunk) - Dose expansion enrollment is now complete, with the full dataset anticipated to be presented by the **end of 2025**[1](index=1&type=chunk)[7](index=7&type=chunk) - The company projects its current cash, cash equivalents, and marketable securities will fund operations into the **second quarter of 2026**[1](index=1&type=chunk)[8](index=8&type=chunk) [Clinical Program Update: Solnerstotug (SNS-101)](index=1&type=section&id=Clinical%20Program%20Update%3A%20Solnerstotug%20%28SNS-101%29) The Phase 1/2 clinical trial for solnerstotug, a conditionally active antibody targeting the VISTA immune checkpoint, has completed its dose expansion enrollment. The trial is evaluating the drug as both a monotherapy and in combination with Libtayo® in patients with advanced solid tumors, with a focus on PD-(L)1 resistant cases - Solnerstotug is a conditionally active antibody designed to selectively target the VISTA immune checkpoint within the tumor microenvironment[4](index=4&type=chunk) - A Phase 1/2 clinical trial is evaluating solnerstotug's safety and efficacy as a monotherapy and in combination with Regeneron's PD-1 inhibitor Libtayo® (cemiplimab)[5](index=5&type=chunk) Dose Expansion Enrollment Completion (Total 63 Patients) | Arm | Patient Group | Number of Patients | | :--- | :--- | :--- | | **Monotherapy** | MSS CRC | 10 | | **Combination (w/ cemiplimab)** | MSS CRC | 10 | | | PD-(L)1 resistant "hot" tumors | 43 | [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) For the first quarter of 2025, Sensei reported a net loss of $6.9 million, a decrease from $8.0 million in the prior-year period. The company's cash position remains strong at $34.3 million. Both R&D and G&A expenses saw year-over-year reductions, primarily due to lower personnel costs Cash Position as of March 31, 2025 | Category | Amount (in millions) | | :--- | :--- | | Cash, cash equivalents and marketable securities | $34.3 | | *Comparison to Dec 31, 2024* | *$41.3* | Quarterly Expense Comparison (Q1 2025 vs Q1 2024) | Expense Category | Q1 2025 (in millions) | Q1 2024 (in millions) | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $3.7 | $4.9 | Decrease | | G&A Expenses | $3.5 | $3.8 | Decrease | Net Loss Comparison (Q1 2025 vs Q1 2024) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net Loss | $6.9 million | $8.0 million | | Net Loss Per Share | $0.27 | $0.32 | [Condensed Statements of Operations](index=3&type=section&id=Condensed%20Statements%20of%20Operations) For the three months ended March 31, 2025, total operating expenses were $7.3 million, down from $8.7 million in the same period of 2024. This led to a reduced net loss of $6.9 million ($0.27 per share) compared to a net loss of $8.0 million ($0.32 per share) in Q1 2024 Statement of Operations (Unaudited, in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | **Total operating expenses** | $7,274 | $8,730 | | **Loss from operations** | $(7,274) | $(8,730) | | **Net loss** | $(6,864) | $(7,992) | | **Net loss per share, basic and diluted** | $(0.27) | $(0.32) | [Selected Condensed Balance Sheet Data](index=3&type=section&id=Selected%20Condensed%20Balance%20Sheet%20Data) As of March 31, 2025, the company held $34.3 million in cash, cash equivalents, and marketable securities. Total assets stood at $38.3 million, with total stockholders' equity at $32.0 million Balance Sheet Data (Unaudited, in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $9,877 | $9,994 | | **Marketable securities** | $24,454 | $31,341 | | **Total assets** | $38,273 | $45,361 | | **Total stockholders' equity** | $31,987 | $38,386 | [Corporate Activities](index=2&type=section&id=Corporate%20Activities) During the first quarter of 2025, CEO John Celebi represented Sensei Biotherapeutics at two key industry conferences, presenting the company's clinical progress and strategic direction to the investment community - Participated in a panel discussion at the Canaccord Genuity Horizons in Oncology Virtual Conference on **April 7, 2025**[13](index=13&type=chunk) - Delivered a presentation at Oppenheimer's 35th Annual Healthcare Life Sciences Conference on **February 11, 2025**[13](index=13&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) The report includes forward-looking statements concerning the potential benefits of its product candidates, clinical trial timelines, and its financial runway. It cautions that these are subject to significant risks and uncertainties, including clinical development failures, trial delays, and reliance on third-party suppliers, which could cause actual results to differ - Statements regarding the development, therapeutic benefits, clinical trial timing, and financial sufficiency (cash runway) are forward-looking[18](index=18&type=chunk) - Key risks include unsuccessful commercialization, trial delays or cessations, non-replication of prior results, and dependence on third-party suppliers[18](index=18&type=chunk)[19](index=19&type=chunk)

Core Insights - Sensei Biotherapeutics reported favorable clinical data for its lead product candidate, solnerstotug, in patients with PD-(L)1-resistant cancers, indicating a potential breakthrough in treatment options for this challenging patient population [2][3] - The company has completed enrollment for its dose expansion cohort and expects to present full data by the end of 2025 [1][6] - Sensei's cash position is strong, with a runway expected to last into the second quarter of 2026 [5] Clinical Development - Solnerstotug is designed to target the immune checkpoint VISTA, which is associated with poor survival rates in various cancers [3] - The ongoing Phase 1/2 clinical trial is evaluating solnerstotug both as a monotherapy and in combination with Regeneron's PD-1 inhibitor, Libtayo [4] - Preliminary data from the trial shows response rates nearly three times higher than historical expectations for PD-(L)1-resistant patients [2][6] Financial Performance - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling $34.3 million, down from $41.3 million at the end of 2024 [5] - Research and Development (R&D) expenses decreased to $3.7 million in Q1 2025 from $4.9 million in Q1 2024, primarily due to lower personnel and facility costs [7] - General and Administrative (G&A) expenses also saw a decrease, totaling $3.5 million in Q1 2025 compared to $3.8 million in Q1 2024 [8] Operational Highlights - The company has completed enrollment of 63 patients in the dose expansion stage, including 10 patients with microsatellite stable colorectal cancer (MSS CRC) and 53 patients with PD-(L)1-resistant "hot" tumors [6] - Sensei participated in various conferences to discuss its clinical progress and strategic direction, enhancing its visibility in the oncology sector [6]

Core Insights - Sensei Biotherapeutics, Inc. is a clinical stage biotechnology company focused on developing next-generation therapeutics for cancer patients [2] - The company will participate in the Canaccord Genuity Horizons in Oncology Virtual Conference on April 7, 2025, with CEO John Celebi as a panelist [1] Company Overview - Sensei Biotherapeutics utilizes its TMAb™ platform to create conditionally active therapeutics that target the tumor microenvironment [2] - The lead product candidate, solnerstotug, is designed to block the VISTA checkpoint selectively in low pH tumor environments, which helps activate T cells against tumors [2]

Therapeutic Development - The company is focused on developing next-generation therapeutics for cancer patients through its TMAb™ platform, which targets immunosuppressive signals in the tumor microenvironment[14]. - Solnerstotug, a conditionally active monoclonal antibody targeting VISTA, is currently in a Phase 1/2 trial with 60 patients dosed as of March 17, 2025[16]. - The company plans to initiate a Phase 2 trial of solnerstotug in Q1 2026, pending sufficient capital[21]. - The TMAb platform is designed to unlock previously undruggable immune targets for oncology applications[18]. - The company has paused development of preclinical product candidates SNS-102, SNS-103, and SNS-201 to focus resources on solnerstotug[17]. - The combination of solnerstotug with cemiplimab showed a 14% objective response rate and a 62% disease control rate among 21 evaluable PD-(L)1 resistant "hot" tumor patients[63]. - Solnerstotug has a greater than 600-fold selective binding affinity for active VISTA at low pH compared to physiological pH[34]. - The company aims to leverage unique tumor features, such as acidity, to design therapeutics that selectively activate within the tumor[19]. - No dose-limiting toxicities were reported for solnerstotug, with the majority of adverse events being Grade 1 or 2[21]. - The pharmacokinetic profile of solnerstotug supports once every three week dosing, demonstrating linear elimination kinetics and dose-proportional increases in exposure[63]. Clinical Trial Results - Clinical data from the trial showed a 14% objective response rate and a 62% disease control rate among 21 evaluable PD-(L)1 resistant "hot" tumor patients[21]. - In the Phase 1/2 clinical trial, 94 patients have been enrolled as of March 17, 2025, with 60 patients dosed in the Phase 1 dose expansion portion[59][62]. - SNS-101 demonstrated significant tumor growth inhibition of 77% when combined with anti-mPD-1 compared to the isotype control group, with a p-value of <0.0001[50]. - SNS-101 was observed to enhance anti-PD-1 response and increase tumor-infiltrating CD8 T cells in VISTA-KI mice[44]. - The combination of SNS-101 with anti-mPD-1 resulted in a 50% survival benefit compared to 12.5% in the anti-mPD-1 alone group[50]. - Solnerstotug was well tolerated, with no dose-limiting toxicities observed, and the majority of adverse events were Grade 1 or 2 in severity[63]. Financial Performance and Funding - The company has incurred significant losses every year since its inception and expects to continue incurring losses over the next several years, with no assurance of achieving profitability[195]. - The company will require substantial additional funding to meet its financial needs and pursue business objectives, with potential delays or reductions in product development if capital is not raised[197]. - The company has primarily financed operations through the sale of equity securities and may seek additional capital through various means, including public or private equity offerings and debt financings[199]. - The company incurred a net loss of $34.1 million for the year ended December 31, 2023, and an accumulated deficit of $262.1 million as of December 31, 2024[207]. - The company expects to continue incurring significant expenses and increasing operating losses for the foreseeable future[209]. - Plans to initiate a Phase 2 clinical trial of solnerstotug in the first quarter of 2026 are contingent upon the ability to raise sufficient additional capital[201]. - The company may need to significantly delay, scale back, or discontinue the development or commercialization of its product candidates if unable to raise additional capital[200]. Regulatory Environment - Regulatory approval processes require significant time and financial resources, with the FDA reviewing biologics through a Biologics License Application (BLA) that must demonstrate safety, purity, and potency[99][112]. - The FDA has a 60-day period to accept a BLA for filing, followed by a ten-month review period for standard applications and six months for priority reviews[115]. - The FDA requires compliance with cGMP regulations for manufacturing facilities before approving a BLA, ensuring consistent production within required specifications[116]. - Orphan drug designation can provide financial incentives such as grant funding opportunities, tax advantages, and user fee waivers, and grants exclusivity for seven years post-approval[118]. - Fast track designation is available for new biological product candidates intended to treat serious conditions, expediting the review process[119]. - Priority review is granted to products that significantly improve safety and effectiveness compared to existing therapies, directing additional resources to their evaluation[121]. - Accelerated approval may be granted if a product shows meaningful advantages over existing therapies and meets specific endpoint criteria[122]. - Breakthrough therapy designation offers intensive guidance from the FDA for products showing substantial improvement over current therapies[123]. - Post-marketing requirements include monitoring adverse experiences and compliance with promotion regulations, with potential penalties for non-compliance[127]. Market Competition - The company operates in a highly competitive market for immunotherapies, with substantial investments made in recent years[89]. - The company faces substantial competition from large pharmaceutical and biotechnology firms, as well as smaller companies forming collaborations to enhance their research and development capabilities[90]. - Competitors include major players like AstraZeneca, Bristol Myers Squibb, and Merck, which have greater financial resources and expertise in research and development[93][94]. - The company’s commercial opportunity may be diminished if competitors develop safer, more effective, or economically beneficial products[96]. - Mergers and acquisitions in the pharmaceutical sector may lead to increased resource concentration among competitors, intensifying competition[94]. Compliance and Legal Risks - Compliance with healthcare laws and regulations is resource-intensive and may divert management's attention from core business operations[138]. - Non-compliance with healthcare laws can result in significant penalties, including civil, criminal, and administrative actions, which could adversely affect business operations[139]. - The company may face challenges from ongoing legislative initiatives aimed at reducing healthcare costs, which could create uncertainty in the market[149]. - Changes in regulations could necessitate modifications to manufacturing arrangements, product labeling, or even lead to product recalls, impacting business operations[137]. - Non-compliance with foreign regulatory requirements may result in fines, product recalls, and other severe consequences[175]. Workforce and Restructuring - The company plans to reduce its workforce by approximately 46% as part of a restructuring plan, incurring costs of $0.7 million primarily for employee termination and severance payments[185]. - As of March 24, 2025, the company had 14 full-time employees and one part-time employee, maintaining a good relationship with its workforce[184]. Economic Factors - Economic downturns, inflation, and geopolitical events may adversely affect the company's business and financial performance[217]. - The Federal Reserve has raised interest rates multiple times in response to inflation concerns, which may increase economic uncertainty and affect financing conditions[219].